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COMPLETED
NCT07896304
PHASE4

Intravenous Dexamethasone to Prolong Caudal Block Analgesia in Children Undergoing Hip Surgery

Sponsor: National Institute of Neurology, Tunisia

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether a single intravenous dose of dexamethasone prolongs postoperative analgesia after a caudal block in children aged 6 months to 9 years undergoing surgery for developmental dysplasia of the hip. The main question it aims to answer is: does intravenous dexamethasone (0.5 mg/kg) lengthen the time to first rescue analgesic compared with placebo? Researchers compared dexamethasone with normal saline (placebo). All children received general anesthesia and a caudal block with bupivacaine 0.25%, and pain was assessed with the CHEOPS score during the first 24 postoperative hours.

Official title: Effect of Intravenous Dexamethasone on the Duration of Caudal Block Analgesia in Children Undergoing Surgery for Developmental Dysplasia of the Hip: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

6 Months - 9 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2019-09-01

Completion Date

2020-12-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Single intravenous dose of 0.5 mg/kg (maximum 10 mg), diluted to 1 mg/ml, given at induction of general anesthesia.

DRUG

Normal Saline

Single intravenous dose of 0.5 ml/kg of 0.9% sodium chloride at induction of general anesthesia, identical in volume to the active solution.

PROCEDURE

Caudal Block Anesthesia

Single-shot caudal epidural block with plain bupivacaine 0.25%, 1 ml/kg, performed after induction with a 22 G short-bevel caudal needle, at least 10 minutes before incision.

Locations (1)

Children's Hospital of Tunis

Tunis, Tunisia